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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032783
Receipt No. R000037399
Scientific Title Prevalence and risk factors of non-alcoholic fatty liver disease (NAFLD) in polycystic ovary syndrome: a cross-sectional study
Date of disclosure of the study information 2018/05/30
Last modified on 2018/11/29

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Basic information
Public title Prevalence and risk factors of non-alcoholic fatty liver disease (NAFLD) in polycystic ovary syndrome: a cross-sectional study
Acronym Prevalence and risk factors of non-alcoholic fatty liver disease (NAFLD) in polycystic ovary syndrome(PR-NAFLD)
Scientific Title Prevalence and risk factors of non-alcoholic fatty liver disease (NAFLD) in polycystic ovary syndrome: a cross-sectional study
Scientific Title:Acronym Prevalence and risk factors of non-alcoholic fatty liver disease (NAFLD) in polycystic ovary syndrome(PR-NAFLD)
Region
Japan

Condition
Condition polycystic ovary syndrome
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the prevalence of NAFLD in polycystic ovary syndrome and risk factors of NAFLD in Japanese women.
Basic objectives2 Others
Basic objectives -Others To investigate the prevalence of NAFLD in polycystic ovary syndrome and risk factors of NAFLD in Japanese women.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Prevalence of NAFLD (Alanine aminotransferase (ALT) > 19 IU/L)
Key secondary outcomes Risk factors of NAFLD

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
50 years-old >
Gender Female
Key inclusion criteria Meet all of the following:
1) Women visited the Department of Gynecology in our Center from January 1, 2000 to September 30, 2016.
2) Women with confirmed diagnosis of polycystic ovary syndrome.
3) ALT data available
Key exclusion criteria Fall under any of the following:
1) Missing data of body height, weight and BMI
2) Women with history of liver diseases
3) Pregnant women
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Yamaguchi
Organization National Hospital Organization Kyoto Medical Center
Division name Department of Obstetrics and Gynecology
Zip code
Address 1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, JAPAN
TEL +81-75-641-9161
Email kyamaguc@kyotolan.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satomi Minato
Organization Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Division name Department of Preventive Medicine
Zip code
Address 1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, JAPAN
TEL +81-75-641-9161
Homepage URL
Email sminato@kyotolan.hosp.go.jp

Sponsor
Institute National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization non
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 05 Month 21 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To investigate the prevalence of NAFLD in polycystic ovary syndrome and risk factors of NAFLD in Japanese women.

Management information
Registered date
2018 Year 05 Month 30 Day
Last modified on
2018 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037399

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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